Protocol summary

Study aim
1- evaluating the efficacy of transcatheter angioembolization for renal trauma following Percutaneous Nephrolithotomy 2- evaluating complications of transcatheter angioembolization for renal trauma following Percutaneous Nephrolithotomy
Design
interventional study without control group, on 60 patients
Settings and conduct
patients who had severe hematuria after PCNL at Sina hospital. inclusion criteria: persistent hemorrhagia after nephrolithotomy, hemoglobin decrease, delayed hemorrhagia which is unresponsive to conservative therapy, exclusion criteria: persistent hypotension,allergy to contrast, patient non consent, coagulopathy, contraindication for contrast injection before angiography, serum Cr, urine analysis and culture test was done and doppler ultrasound of kidneys was performed. ultrasound findings such as pseudoaneurysm , AVF and hematoma was recorded. after patients informed consent, angiography and angioembolization was done. the patient follow up will be done considering hematuria cessation, need for transfusion or surgery and procedure complications such as renal artery damage, creatinin rise and renal abcess
Participants/Inclusion and exclusion criteria
patients who had severe hematuria after Percutaneous Nephrolithotomy (PCNL) at Sina hospital. inclusion criteria: persistent hemorrhagia after nephrolithotomy, hemoglobin decrease, delayed hemorrhagia which is unresponsive to conservative therapy, exclusion criteria: persistent hypotension,allergy to contrast, patient non consent, coagulopathy, contraindication for contrast injection
Intervention groups
Angioembolization with coil was done for the patients who had severe or persistent hematuria after PCNL
Main outcome variables
hematuria cessation, probable complications

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230715058782N1
Registration date: 2023-08-05, 1402/05/14
Registration timing: registered_while_recruiting

Last update: 2023-08-05, 1402/05/14
Update count: 0
Registration date
2023-08-05, 1402/05/14
Registrant information
Name
Mohammad Ashouri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6119 2606
Email address
m-ashouri@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-01, 1402/05/10
Expected recruitment end date
2024-07-25, 1403/05/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
evaluating the efficacy of transcatheter angioembolization for renal trauma following Percutaneous Nephrolithotomy
Public title
Efficacy of Angoembolization on post PCNL persistent Hematuria
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Persistent Hematuria after PCNL Hemoglobin drop needing transfusion Delayed persistent hematuria
Exclusion criteria:
hypotension allergy to iodine contrast coagulopathy contraindication for iodine contrast patient refusal
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Surgery Ward 3&4, Imam khomeini Hospital complex, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Approval date
2023-06-06, 1402/03/16
Ethics committee reference number
IR.TUMS.SINAHOSPITAL.REC.1402.030

Health conditions studied

1

Description of health condition studied
injury of renal blood vessels post PCNL
ICD-10 code
S35.4
ICD-10 code description
Injury of renal blood vessels

Primary outcomes

1

Description
Hematuria cessation
Timepoint
daily control after angioembolization
Method of measurement
urine appearance

2

Description
serum creatinine
Timepoint
before and 2days after angioembolization
Method of measurement
laboratory

3

Description
hemoglobin
Timepoint
before and daily after angioembolization
Method of measurement
Laboratory

4

Description
Packed RBC need for hemodynamic stability
Timepoint
before and after angioembolization
Method of measurement
transfused Packed cell

5

Description
Angiographic complications
Timepoint
After angioembolization
Method of measurement
complications related to angioembolization detected by sonography

6

Description
Need to operation for bleeding control
Timepoint
daily after angioembolization
Method of measurement
Operation for control of hematuria

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Patient who underwent PCNL and suffer from persistent severe hematuria needing transfusion and patient with delayed hematuria without proper response to conservative treatments are included and undergo transcatheter angiography and if vascular injury is detected angioembolization with coil (COOK Medical) will perform to stop blood flow to the injured vessel
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Mohammad Ashouri
Street address
Surgery ward 3&4, Imam khomeini hospital complex, Keshavarz blvd.
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 912 618 3895
Email
m-ashouri@tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotouhi
Street address
qos ave. Keshavarz blvd.
City
Tehran
Province
Tehran
Postal code
1419836365
Phone
+98 21 8899 2970
Email
afotouhi@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ashouri
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Imam Khomeini Avenue
City
Tehran
Province
Tehran
Postal code
1419836365
Phone
+98 21 6119 2606
Fax
Email
m-ashouri@tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ashouri
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Imam Khomeini Avenue
City
Tehran
Province
Tehran
Postal code
1419836365
Phone
+98 21 6119 2606
Fax
Email
m-ashouri@tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ashouri
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Imam Khomeini Avenue
City
Tehran
Province
Tehran
Postal code
1419836365
Phone
+98 21 6119 2606
Fax
Email
m-ashouri@tums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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